UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007642 |
|---|---|
| Receipt number | R000009013 |
| Scientific Title | PGx-based anti-coagulant therapy with Warfarin Dosing |
| Date of disclosure of the study information | 2012/04/03 |
| Last modified on | 2017/04/04 18:22:58 |
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Basic information
Public title
PGx-based anti-coagulant therapy with Warfarin Dosing
Acronym
P-ACTWAD
Scientific Title
PGx-based anti-coagulant therapy with Warfarin Dosing
Scientific Title:Acronym
P-ACTWAD
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluate the genotype-based dosing algorithm for warfarin in anti-coagulant therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration required for determination of stable maintenance dose.
(The number of visits to the hospital and the changes in dose from initial to final dose until reaching the target INR (1.8 to 3.0) for the second time in a row.)
Key secondary outcomes
1)The bleeding events or thromboembolic events.
2)Any other adverse clinical events.
3)The number of adjustment of warfarin dose.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Determine the initial dose by the genotype-based algorithm (intervention group)
Interventions/Control_2
Initiation of warfarin treatment at 1.5 mg/day. (control group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who will take warfarin.
2) Patients who are 20-80 years old.
3) Patients who will voluntarily give written an informed consent.
Key exclusion criteria
1) Patients who have taken warfarin before.
2) Patients who urgently have to start anti-coagulant therapy.
3) Patients with a history of the prosthetic valve replacement.
4) Patients for whom target INR 2.0-3.0 are inadequate.
5) Patients with a severe hepatic or renal disorder.
6) Patients with thyroid dysfunction.
7) Patients who are applicable to contraindication to warfarin therapy.
8) Patients who take medicines that interact with warfarin.
9) Patients who cannot understand or practice the dietary instruction.
10) Patients judged by investigators as ineligible for study enrollment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinpei Nonen |
Organization
Hyogo University of Health Sciences
Division name
School of Pharmacy
Zip code
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3149
nonen@huhs.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinpei Nonen |
Organization
Hyogo University of Health Science
Division name
School of Pharmacy
Zip code
Address
1-3-6, Minatojima Chuo-ku, Kobe, Hyogo
TEL
078-304-3149
Homepage URL
nonen@huhs.ac.jp
Sponsor or person
Institute
Hyogo University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science & Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka City University
Hyogo College of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 02 | Day |
Last modified on
| 2017 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009013
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
